FDA.reportPublic FDA data

Application 020908

Type
NDA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VAGIFEMESTRADIOLTABLET;VAGINAL25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002VAGIFEMESTRADIOLTABLET;VAGINAL10MCGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-5176VagifemestradiolNovo NordiskNDACurrent
0169-5176VagifemestradiolNovo NordiskNDACurrent
0169-5176VagifemestradiolNovo NordiskNDACurrent
0169-5176VagifemestradiolNovo NordiskNDACurrent
0169-5176VagifemestradiolNovo NordiskNDACurrent
0169-5176VagifemestradiolNovo NordiskNDACurrent
69238-1524YuvafemEstradiolAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent
69238-1524YuvafemEstradiolAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69238-1524YuvafemEstradiolAmneal Pharmaceuticals NY LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77564SUPPL 2024-02-20
77540SUPPL 2024-02-16
76731SUPPL 2023-12-05
76729SUPPL 2023-12-05
72221SUPPL2022-10-03
72193SUPPL2022-09-30
65839SUPPL2021-01-07
58274SUPPL2019-04-10
58272SUPPL2019-04-10
50285SUPPL2017-11-03
47465SUPPL2017-03-03
47391SUPPL2017-03-02
35627SUPPL2012-04-17
26176SUPPL2012-04-13
3721SUPPL2011-05-19
35626SUPPL2009-12-02
21272ORIG2005-07-15
26175ORIG1999-03-26
13725ORIG1999-03-26